Virtual Care to Improve Heart Failure Outcomes (VITAL-HF)
Heart Failure With Reduced Ejection Fraction
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction
Eligibility Criteria
Inclusion Criteria: Age >18 years of age Diagnosis of HF and LVEF <40% on most recent imaging assessment within 1 year prior to screening. Any validated method for assessing LVEF may be used for enrollment including echocardiogram, cardiac magnetic resonance imaging, etc. For participants with an LVEF reported qualitatively (e.g., moderate LV dysfunction) or as a range on the most recent imaging assessment that includes 40% (e.g., 35-45%), then the site investigator should review the imaging study and determine if the participant has an LVEF <40%. Participants with a new diagnosis of HFrEF may be enrolled. The enrollment will be monitored to ensure no more than 50% of the total cohort have new-onset HFrEF. Access to a smartphone including through a family member of caregiver Fluent in written and spoken English Exclusion Criteria: Optimized or nearly-optimized on evidence-based medical therapies for HFrEF as determined by local investigator. Current pregnancy Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine eGFR of <20 mL/min/1.73m2 or ongoing chronic dialysis at screening Prior heart transplant Current or planned left ventricular assist device Currently receiving hospice care Chronically resides in an assisted living or skilled nursing facility where food and medications are managed by facility personnel Terminal illness other than HF with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
Sites / Locations
- Cardiovascular Institute of Northwest FloridaRecruiting
- Ascension St. VincentRecruiting
- The University of Kansas Medical CenterRecruiting
- Minneapolis Heart Institute FoundationRecruiting
- Saint Luke's Health SystemsRecruiting
- Duke UniversityRecruiting
- Cleveland ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Digital Heart Failure Medication Titration
Usual Care
The Story Health platform will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. Participants will also report any symptoms. All of this data will be transmitted, via the platform, to the treating clinician at the site, who will create care plans for medication titration and make clinical decisions. The care plans will be implemented with assistance from health coaches from Story Health Inc.
Routine clinical care will be followed. Participants will also receive a blood pressure cuff and scale, though the data will not be routinely fed back to the treating clinicians unless requested.